MedDataX Logo

Impact of Oral Diets on Postoperative Fluid Collection

NCT ID: NCT05068882

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arm randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immunonutrition

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Group Type EXPERIMENTAL

Immunonutrition

Intervention Type DIETARY_SUPPLEMENT

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

High-protein diet

Oral nutrition with high-protein content

Group Type ACTIVE_COMPARATOR

High-protein nutrition

Intervention Type DIETARY_SUPPLEMENT

Oral nutrition with high-protein content

Standard nutrition

Oral nutrition with standard ingredients

Group Type ACTIVE_COMPARATOR

Standard nutrition

Intervention Type DIETARY_SUPPLEMENT

Oral nutrition with standard ingredients

No intervention

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immunonutrition

Oral immunonutrition containing arginine, omega-PUFAs and antioxidants

Intervention Type DIETARY_SUPPLEMENT

High-protein nutrition

Oral nutrition with high-protein content

Intervention Type DIETARY_SUPPLEMENT

Standard nutrition

Oral nutrition with standard ingredients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* confirmed breast cancer or melanoma
* scheduled surgery with axillary lymph nodes resection
* informed consent
* eligible for surgery

Exclusion Criteria

* benign disease
* no consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stanislaw Klek

Head of the Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stanislaw Klek, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanley Dudrick's Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maria Sklodowska-Curie National Cancer Institute

Krakow, Malopolska, Poland

Site Status RECRUITING

Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stanislaw Klek, PhD

Role: CONTACT

[email protected]
+48604293566

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Narodowy I Onkologii

Role: primary

[email protected]
60293566

Stanislaw Klek, Assoc. Prof.

Role: primary

[email protected]
+48604293566

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BC1

Identifier Type: -

Identifier Source: org_study_id